BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSYN VIOLET 3/0(2)4X45CM HR22TO(M)

    MDR report key: 8647735 · Received May 28, 2019

    Report

    Report Number
    3003639970-2019-00440
    Event Type
    Malfunction
    Date Received
    May 28, 2019
    Report Date
    May 28, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    PMA / PMN Number
    K122734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER, REGISTRATION NO. 3003639970). EXEMPTION NUMBER: E2014012. MANUFACTURING SITE EVALUATION: ANALYSIS AND RESULTS - THERE ARE NO SAMPLES AVAILABLE FOR ANALYSIS, HOWEVER, PICTURE WAS PROVIDED. THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE NOT RECEIVED ANY SAMPLE FROM THE CUSTOMER. NEVERTHELESS, WE HAVE RECEIVED A PICTURE THAT SHOWS ONE OPEN AND UNUSED SAMPLE THAT CONTAINS FIVE SUTURES INSIDE THE PACK INSTEAD OF FOUR AS INDICATED IN THE PRODUCT DESCRIPTION. REVIEW OF THE BATCH MANUFACTURING RECORDS SHOWED THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. TAKING INTO ACCOUNT THAT NO OTHER CUSTOMER COMPLAINTS HAVE BEEN RECEIVED FOR THIS CODE-BATCH, WE CONSIDER THAT THIS IS AN ISOLATED AND ACCIDENTAL UNIT CAUSED BY A HUMAN MISTAKE DURING PRODUCTION PROCESS. INVOLVED PERSONNEL WILL BE INFORMED ABOUT THIS INCIDENCE. FINAL CONCLUSION - TAKING INTO ACCOUNT THAT THE PICTURE RECEIVED SHOWS A SAMPLES THAT DOES NOT FULFIL B. BRAUN SURGICAL SPECIFICATIONS, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED BY EVIDENCE OF FAILURE IN THE PICTURE RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE SUTURE. AFTER OPENING THE PACKET, IT WAS NOTED THAT THERE WERE 5 NEEDLES INSTEAD OF 4. IT WAS NOT USED ON A PATIENT. A PICTURE CONFIRMED THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439613 NOVOSYN VIOLET 3/0(2)4X45CM HR22TO(M) SYNTHETIC ABSORBABLE BRAIDED GAM B.BRAUN SURGICAL SA C0088730 718433

    Patients

    Seq Age Sex Outcome Treatment
    1